The meeting was held at the Holiday Inn, in Gaithersburg, Maryland. Prior to the meeting, the members, consultants and guests had reviewed background material from the FDA. In order for the public to be informed, the background material was also available on the Dockets page before the meeting. There were approximately 250 persons in attendance. The meeting started at 8 a.m. and ended at 5:00 p.m.

The committee did not vote on the questions. The committee and guests discussed the issues and their views are recorded in the transcript. A verbatim transcript of this meeting will be available on the FDA’s Dockets Management Branch Website approximately 30 days after the meeting. The address is